Delivery Room Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) in Extremely Low Birth Weight (ELBW) Infants
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Infant, Newborn
- Sponsor
- NICHD Neonatal Research Network
- Enrollment
- 104
- Locations
- 6
- Primary Endpoint
- Compliance with the study protocol
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants <28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP and no PEEP if the infant required PPV (the control group).
Detailed Description
Previous studies suggested that early continuous airway positive pressure (CPAP) may be beneficial in reducing ventilator dependence and subsequent bronchopulmonary dysplasia (BPD) in extremely low birth weight (ELBW) infants. These studies did not test for the optimal timing of CPAP initiation or compare CPAP/PEEP initiation in the delivery room against standard resuscitation methods. Current practice at the time was for the ELBW infant to be intubated early and administered prophylactic surfactant. The feasibility of initiating CPAP in the DR and continuing this therapy without intubation for surfactant had not been determined prospectively in a population of ELBW infants. This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants \<28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP and no PEEP if the infant required PPV (the control group).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Infants delivered in a specially equipped resuscitation room(s)
- •\<28 weeks gestational age by best obstetric estimate before delivery
- •Requiring resuscitation
Exclusion Criteria
- •No known major congenital anomalies
- •Decision made not to provide full resuscitation
Outcomes
Primary Outcomes
Compliance with the study protocol
Time Frame: 6 months
Secondary Outcomes
- Extent of resuscitation needed(Until admission to NICU)
- Bronchopulmonary dysplasia (BPD)(36 weeks of life)
- Number and duration of intubation attempts(Until admission to the NICU)
- Infants who required positive pressure ventilation for resuscitation in the DR/resuscitation room(Until admission to the NICU)
- Five minute Apgar(5 minutes after birth)
- Total duration of mechanical ventilation(Until hospital discharge or 120 days of life)
- Proportion of infants requiring surfactant(1 day of life)